USE THE SYSTEMIC METFORMIN IN MELASMA

August 1, 2021 updated by: Karima Nageh, Assiut University

THE METFORMIN AND TRICHLOROACETIC ACID IN TREATMENT OF MELASMA

Melasma is a chronic and relapsing acquired dyschromia due to an increased epidermal-melanin unit activity that affects sun-exposed areas mainly in women throughout the reproductive years. It is more common in women, accounting for 90% of all cases.The majority of patients are in third and fourth decades of their life. There are several risk factors that influence its appearance including genetic predisposition,exposure to heat and UV radiation, pregnancy, and exogenous hormones (such as oral contraceptives,thyroid hormones, and hormone replacement therapy). Other factors implicated are phototoxic drugs, anticonvulsant medications,and the use of certain cosmetics. Types of melasma are epidermal, dermal and mixed according to location of melanin.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Its pathogenesis is not fully understood, nevertheless there is evidence that melanogenesis in melasma differ from tanning and post-inflammatory hyperpigmentations as well as there is an involvement of the whole epidermal melanin unit in the process (not just hypertrophic melanocytes), mastocytes, fibroblast and endothelium derived cytokines, as well as there are upper dermal abnormalities different from other acquired pigmentary disorders. Patients with melasma have also been found to have higher markers of oxidative stress status.

Melasma has significant impact on patients physical health, interpersonal relationships ,social-well being and self- esteem as they refused to leave their house, felt inferior to others, and incessantly thought about their melasma being.

Melasma is often resistant to treatment and frustrating for both patients and clinician. In spite of presence of several methods for treatment of melasma exacted as, Topical compounds that include the Kligman's formula which is the triple combination of ( retinoid, hydroquinone, and steroid) and azelaic. Chemical peels (e.g., glycolic, β hydroxyl, and trichloroacetic acid )although these must be used cautiously in patients with darker skin. Laser and Light therapies represent potentially promising options for patients who are refractory to other modalities, but they also carry significant risk of worsening the disease.

Recently, some reports refer to the use of metformin in treatment of melasma. Metformin is antidiabetic drugs that was shown to exert its biological effect by decreasing cyclic adenosine phosphate , which is a well known modulator of melanin synthesis. Metformin decreased skin pigmentation in vivo with minimal side effects, suggesting a potential application of metformin in the treatment of hyperpigmentation disorders. Where the metformin was applied topically onto a mouse tail, whitening of the tail was observed. In addition, metformin decreased the epidermal level of melanin when metformin was applied to human skin punch biopsies and to reconstructed human epidermis. When melanocytes were treated with metformin, basal level of total melanin (eumelanin and pheomelanin) were reduced significantly. Also metformin blocked forskolin and alpha melanocyte-stimulating hormone which increase the levels of melanin. Metformin decrease levels of tyrosinase, tyrosinase-related protein-1 and tyrosinase-related protein-2.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Assiut, Egypt, 71111
        • Recruiting
        • Assuit university
        • Contact:
          • Radwa Bakr
          • Phone Number: 01119988115
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. All patients above 18 years old with melasma.
  2. With Fitzpatrick skin phototypes ranging from Type III-V will recruited.

Exclusion Criteria:

  1. Pregnant or nursing women.
  2. Current use of hormonal birth control medication or any hormonal therapy, Use of topical hydroquinone within 3 months of study, Use of topical steroids within 1 month of study, Regular use of tanning parlors and History of laser or dermabrasion to the face within 9 months of study.
  3. Occupation involving primarily outdoor activities.
  4. History of kidney dysfunction diabetic (excluded by history and laboratory), Significant cardiovascular or respiratory disease and any other systemic diseases(i.e,history of endocrine disorders).
  5. patients with poor wound healing, recurrent herpes labialis and current skin infection (facial warts, molluscum contagiosum, history of hypertrophic scar/keloids, active dermatosis of atopic, seborrheic or other eczematous type).
  6. Photosensitivity,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: control group
Drug: Trichloroacetic Acid Peeling
Trichloroacetic acid peeling to the three groups
Drug: Placebos
oral placebos will be given to control beside trichloracetic acid peeling
Experimental: study Metformin 1000 mg
Drug: MetFORMIN 1000 Mg Oral Tablet
oral tablet 1ooomg systemic metformin will be given to group
Other Names:
  • Glucophage
Drug: Trichloroacetic Acid Peeling
Trichloroacetic acid peeling to the three groups
Experimental: study Metformin 500 mg
Drug: Trichloroacetic Acid Peeling
Trichloroacetic acid peeling to the three groups
Drug: MetFORMIN 500 Mg Oral Tablet
oral tablet 500 mg
Other Names:
  • Glucophage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
degree of improvement of melasma
Time Frame: up to 3 months

Melasma Area and Severity Index score will be calculated for patients before and after treatment to all patientsscore is calculated by multiplying the area of involvement with the square of pigmentation as given in the formula:

MSI = 0.4 (a × p 2 ) l + 0.4 (a × p 2 ) r + 0.2 (a × p 2 ) n

In the formula, "a" stands for "area of involvement," "p" for "severity of pigmentation," "l" for left face, "r" for right face, and "n" for nose.

The area involved, as well as the severity of pigmentation is scored from 0 to 4Score 0:No visible pigmentation,score 1 :rarely visible pigmentation scor e 2:mild pigmentation score3: moderate pigmentation score 4:sever pigmentation.scoringfor area of involvement less than or equal 10% area involved-scor1,11-30%-score2 ,31-60%-score3 and more than 60%-score 4

. patient will be photographed at baseline and after every two weeks interval and one month after the last session
up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Anticipated)

August 1, 2021

Study Completion (Anticipated)

August 1, 2021

Study Registration Dates

First Submitted

March 14, 2018

First Submitted That Met QC Criteria

March 22, 2018

First Posted (Actual)

March 23, 2018

Study Record Updates

Last Update Posted (Actual)

August 3, 2021

Last Update Submitted That Met QC Criteria

August 1, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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